23 May 2018 - - Lund, Sweden-based mitochondrial medicine company NeuroVive Pharmaceutical AB (NASDAQ Stockholm: NVP; OTCQX: NEVPF) and Seoul, South Korea-based pharmaceutical company Yungjin Pharm Corp. Ltd (South Korea Stock Market: KRX 003520) have released positive topline results after data base lock in the phase I single ascending dose clinical study of KL1333, a novel treatment in clinical development for orphan genetic mitochondrial diseases, the companies said.
Review of the phase I data shows that KL1333 has a highly favourable and very clear dose-proportional pharmacokinetic profile. There were no serious adverse events, and only mild gastrointestinal adverse events were recorded at higher doses.
Based on the positive PK and safety results NeuroVive is moving rapidly to initiate the next study in Europe that will include repeated dosing (multiple ascending dose; MAD) in healthy volunteers and patients.
The MAD study will consist of two parts; a dose escalation in healthy volunteers, and also multiple dosing of patients with genetic mitochondrial disease. The purpose of the study is to further investigate safety and pharmacokinetics of KL1333 prior to initiating a phase II efficacy clinical trial. The study will be conducted at sites in the UK.
KL1333 is a potent modulator of the cellular levels of NAD+, a central coenzyme in the cell's energy metabolism.
Preclinical models have demonstrated an increase mitochondrial energy output, reduced lactate accumulation, diminished formation of free radicals, and long-term beneficial effects on energy metabolism, such as the formation of new mitochondria.
NeuroVive's R and D portfolio consists of several late stage research programs in areas ranging from genetic mitochondrial disorders to cancer and metabolic diseases such as NASH. The company's strategy is to advance drugs for rare diseases through clinical development and into the market.
Yungjin Pharm is committed to the development of innovative products and business excellence in both overseas and domestic segments.